Cited by 162CAR-T cell therapy researchMesenchymal stem cell researchBiomedical Ethics and Regulation

Cell therapies in the clinic

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Wang, Lily Li‐Wen, Janes, Morgan E., Kumbhojkar, Ninad, Kapate, Neha, Clegg, John R., Prakash, Supriya, Heavey, Mairead K., Zhao, Zongmin +2 more·2021·Bioengineering & Translational Medicine

Abstract

Cell therapies have emerged as a promising therapeutic modality with the potential to treat and even cure a diverse array of diseases. Cell therapies offer unique clinical and therapeutic advantages over conventional small molecules and the growing number of biologics. Particularly, living cells can simultaneously and dynamically perform complex biological functions in ways that conventional drugs cannot; cell therapies have expanded the spectrum of available therapeutic options to include key cellular functions and processes. As such, cell therapies are currently one of the most investigated therapeutic modalities in both preclinical and clinical settings, with many products having been approved and many more under active clinical investigation. Here, we highlight the diversity and key advantages of cell therapies and discuss their current clinical advances. In particular, we review 28 globally approved cell therapy products and their clinical use. We also analyze >1700 current active clinical trials of cell therapies, with an emphasis on discussing their therapeutic applications. Finally, we critically discuss the major biological, manufacturing, and regulatory challenges associated with the clinical translation of cell therapies.

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  • Non-genetically modified cell therapies and their derived extracellular vesicles are particularly promising because of lower regulatory complexity and potential for earlier clinical adoption.

    “Among these, non-genetically modified cell therapies and their derived extracellular vesicles (EVs) are particularly promising because of their lower regulatory complexity and potential for earlier clinical adoption (Wang et al., 2021; Bahmani and Ullah, 2022; Thom and Cronin, 2024).”

    From Isolator-based point-of-care manufacturing: a practical solution for GMP-compliant cell and extracellular vesicles therapy production (2025) · cites this paper as Wang et al., 2021

    The Biological challenges section (page unavailable) describes non-genetically modified cells as a potentially useful alternative to genetic modification in clinical settings. The Regulatory challenges section (page unavailable) discusses approval barriers for cell therapies generally, but does not say that non-genetically modified therapies or their extracellular vesicles have lower regulatory complexity or could be adopted earlier. The retrieved passages do not address extracellular vesicles. (LLM, conf=0.84)

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Authors
Wang, L. L., Janes, M. E., Kumbhojkar, N., Kapate, N., Clegg, J. R., Prakash, S., Heavey, M. K., Zhao, Z., Anselmo, A. C., & Mitragotri, S.
Affiliations
  • John A. Paulson School of Engineering & Applied Sciences Harvard University Cambridge Massachusetts USA
  • Harvard University (US)
  • University of North Carolina at Chapel Hill (US)
Corresponding author
  • Anselmo, Aaron C.
  • Mitragotri, Samir
Venue
Bioengineering & Translational Medicine
Publisher
Wiley
Published
2021-02-26
Volume
6
Issue
2
Pages
e10214-e10214
ISSN
2380-6761 (ISSN-L)
OpenAlex
W3133159755
Cited by
162
References
15
Citations by year
2026: 28 · 2025: 28 · 2024: 41 · 2023: 32 · 2022: 23 · 2021: 9
FWCI
3.18
Type
journal article
Language
en
Open access
Locations
  • Bioengineering & Translational Medicine (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • UNC Libraries
Funders
  • National Institutes of Health (1R01HL143806‐01, R35GM137898)
  • National Science Foundation
  • U.S. Department of Defense (W81XWH‐19‐2‐0011)
Topics
  • Health Sciences › Medicine › Oncology › CAR-T cell therapy research
  • Health Sciences › Medicine › Genetics › Mesenchymal stem cell research
  • Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
Keywords
cell therapy, clinical trials, clinical translation, cell therapy manufacturing, regulatory challenges, therapeutic applications

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

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